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PubMed Journals Articles About "Sunovion Announces Acceptance Review Drug Application Dasotraline" RSS

00:17 EDT 20th October 2018 | BioPortfolio

Sunovion Announces Acceptance Review Drug Application Dasotraline PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Sunovion Announces Acceptance Review Drug Application Dasotraline articles that have been published worldwide.

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Showing "Sunovion Announces Acceptance Review Drug Application Dasotraline" PubMed Articles 1–25 of 31,000+

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a huma...


Relationship Between the Review Time and Various PMDA Consultations in Recent New Drug Approval Cases in Japan.

It is considered important that the applicants and reviewers communicate well from the development stage and that both mutually understand the development strategy and application contents in conducting the review efficiently after the application is submitted. Therefore, we focus on Pharmaceuticals and Medical Devices Agency (PMDA) consultations from the viewpoint of communication before the application and clarify the issues to consider in the challenge to reduce the review time in terms of the relationsh...

Improving sensory acceptance and physicochemical properties by ultrasound application to restructured cooked ham with salt (NaCl) reduction.

The objective of this research was to study the effects of salt reduction and the application of ultrasound (nominal current of 600 W cm for 10 min) on the physicochemical properties, the microstructure and the sensory acceptance of restructured cooked ham. Four treatments with reduced salt including one with the application of ultrasound (1.5, 1.12, 0.75 and 0.75% salt + ultrasound) were produced. The treatment with 0.75% salt provided a reduction of about 30% in the sodium content. The use of ultras...


Consumer acceptance of cultured meat: A systematic review.

Cultured meat grown in-vitro from animal cells is being developed as a way of addressing many of the ethical and environmental concerns associated with conventional meat production. As commercialisation of this technology appears increasingly feasible, there is growing interest in the research on consumer acceptance of cultured meat. We present a systematic review of the peer-reviewed literature, and synthesize and analyse the findings of 14 empirical studies. We highlight demographic variations in consumer...

Moving average quality control: principles, practical application and future perspectives.

Moving average quality control (MA QC) was described decades ago as an analytical quality control instrument. Although a potentially valuable tool, it is struggling to meet expectations due to its complexity and need for evidence-based guidance. For this review, relevant literature and the world wide web were examined in order to (i) explain the basic concepts and current understanding of MA QC, (ii) discuss moving average (MA) optimization methods, (iii) gain insight into practical aspects related to apply...

Acceptance and Commitment Therapy in cancer: Review of applications and findings.

This study aimed to analyse published studies regarding the usefulness of Acceptance and Commitment Therapy in the treatment of oncological patients. A systematic review of the literature was conducted using the Web of Science, Google Scholar and Dialnet (2000-2016). Nineteen articles fulfilled the inclusion criteria. Those patients who received interventions based on Acceptance and Commitment Therapy showed a better emotional state and quality of life and greater psychological flexibility. Acceptance and C...

Adoption of E-Government Applications for Public Health Risk Communication: Government Trust and Social Media Competence as Primary Drivers.

Building upon a framework of the unified theory of acceptance and use of technology, this study explores the determinants of citizens' intentions to use the government's mobile application for public health risk communication. An online survey was conducted with a quota sample of 700 Korean citizens. The results from structural equation modeling suggest that social media competence and trust in government information are primary determinants of willingness to accept the new application and intention to use ...

Pharmacological Properties of Geraniol - A Review.

Geraniol is an acyclic isoprenoid monoterpene isolated from the essential oils of aromatic plants including , and several other plants. The limited source of geraniol from plant isolation cannot fulfill the great demand from the flavor and fragrance industries, which require maximizing geraniol production through biotechnology processes. The diverse activities of geraniol suggested that geraniol could treat various diseases as a promising drug candidate. In order to evaluate the potential of geraniol applie...

Matrix Metalloprotease Triggered Bioresponsive Drug Delivery Systems - Design, Synthesis and Application.

Engineering of drug delivery systems has evolved in recent decades from comparably simple designs that merely controlled drug release to complex, often multistage systems that respond to multiple biological or environmental stimuli. Matrix metalloproteases (MMPs) are a family of proteolytic enzymes that are involved in numerous physiologic and pathophysiologic processes, including cancer. Therefore, these enzymes represent highly relevant targets for the development of novel bioresponsive drug delivery syst...

Application of polydopamine in tumor targeted drug delivery system and its drug release behavior.

Inspired by the bionics of marine mussels, polydopamine (PDA), a new polymer with unique physicochemical properties was discovered. Due to its simple preparation, good biocompatibility, unique drug-loading methods, PDA has attracted tremendous attentions in field of drug delivery and imaging, and the combination of chemotherapy and other therapies or diagnostic methods, such as photothermotherapy (PTT), photoacoustic imaging (PAI), magnetic resonance imaging (MRI), etc. As an excellent drug carrier in tumor...

AIEgen based drug delivery systems for cancer therapy.

Fluorescent drug delivery systems provide a means to track drug release, trace processes of translocation, monitor excretion of anticancer agents and predict therapeutic responses. Traditional fluorescent dye-labeled drug delivery systems often suffer from notorious aggregation-caused quenching (ACQ) with greatly impeded imaging performance. The emerging fluorogens with aggregation-induced emission characteristics (AIEgens) have provided an elegant alternative to tackle this challenge. Recently, fluorescent...

Poly (amidoamine) (PAMAM) dendrimer mediated delivery of drug and pDNA/siRNA for cancer therapy.

Poly (amidoamine) (PAMAM) dendrimers are well-defined, highly branched macromolecules with numerous active amine groups on the surface. Because of their unique properties, PAMAM dendrimers have steadily grown in popularity in drug delivery, gene therapy, medical imaging and diagnostic application. This review focuses on the recent developments on the application in PAMAM dendrimers as effective carriers for drug and gene (pDNA, siRNA) delivery in cancer therapy, including: a) PAMAM for anticancer drug deliv...

Nanoemulsions in drug delivery: formulation to medical application.

Nanoscale oil-in-water emulsions (NEs), heterogeneous systems of two immiscible liquids stabilized by emulsifiers or surfactants, show great potential in medical applications because of their attractive characteristics for drug delivery. NEs have been explored as therapeutic carriers for hydrophobic compounds via various routes of administration. NEs provide opportunities to improve drug delivery via alternative administration routes. However, deep understanding of the NE manufacturing and functionalization...

VA Announces Plan to Improve Worst-Performing Medical Centers.

Fabrication and application of BN nanoparticles, nanosheets and their nanohybrids.

Smart implementation of novel advanced nanomaterials is the key for the solution of many complex problems of modern science. In recent years, there has been a great interest in the synthesis and application of boron nitride (BN) nanotubes because of their unique physical, chemical, and mechanical properties. By contrast, the synthesis, characterization and exploration of other morphological types of BN nanostructure - BN nanoparticles and BN nanosheets - have received less attention. However, the detailed i...

Functionalization of graphene family nanomaterials for application in cancer therapy.

Graphene family nanomaterials' (GFN) ability to interact with near-infrared light has propelled their application in cancer photothermal therapy. Furthermore, the graphitic lattice of GFN can adsorb different types of molecules, which has motivated their use in cancer drug delivery. However, the direct application of GFN in cancer therapy is severely hindered by their poor colloidal stability, sub-optimal safety, inefficient tumor uptake and non-selectivity towards cancer cells. To overcome these limitation...

Factors Affecting Consumer Acceptance of an Online Health Information Portal Among Young Internet Users.

Despite the proliferation of health and nursing informatics applications in the past decade, factors influencing consumer acceptance of the applications are not well understood. This study was conducted to investigate factors affecting acceptance of a consumer-used nursing informatics application (ie, online health information portal) within the framework of the Technology Acceptance Model. A cross-sectional study was conducted in which 201 Chinese young adults were invited to participate in usability testi...

Public Acceptance of Fully Automated Driving: Effects of Social Trust and Risk/Benefit Perceptions.

Automated driving (AD) is one of the most significant technical advances in the transportation industry. Its safety, economic, and environmental benefits cannot be realized if it is not used. To explain, predict, and increase its acceptance, we need to understand how people perceive and why they accept or reject AD technology. Drawing upon the trust heuristic, we tested a psychological model to explain three acceptance measures of fully AD (FAD): general acceptance, willingness to pay (WTP), and behavioral ...

Evaluation of preventable adverse drug reactions by implementation of the nationwide network of prospective drug utilization review program in Korea.

A prospective Drug Utilization Review (DUR) program has been implemented in Korea to improve the quality and safety of medication use.

Prevalence of drug use among students in mainland China: A systematic review and meta-analysis for 2003-2013.

In response to calls to reassess and reform international drug policy, we estimated the prevalence of drug use among students in China from 2004 to 2013 through a systematic review and meta-analysis.

Therapeutic Drug Monitoring of Antiepileptic Drugs in Epilepsy: A 2018 Update.

Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Since 1989, 18 new AEDs have been licensed for clinical use and there are now 27 licensed AEDs in total for the treatment of patients with epilepsy. Furthermore, several AEDs are also used for the management of other medical conditions, e.g., pain and bipolar disorder. This has led to an increasingly widespread application of therapeutic drug monitoring (TDM) of AEDs, making AEDs among the most common medications for which TDM is performed. ...

Application of in vitro CYP and transporter assays to predict clinical drug-drug interactions.

An LC-MS/MS method for absolute quantification of nivolumab in human plasma: application to clinical therapeutic drug monitoring.

Nivolumab is a fully humanized IgG4 monoclonal antibody that targets the programmed death-1 (PD-1) receptor, disrupting PD-1-mediated signaling and restoring antitumor immunity. The objective of this study was to develop a nivolumab quantification method using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to evaluate its application in clinical therapeutic drug monitoring.

Analytical Target Profile: establishment of precision requirements for assay.

Approaches are presented to establish precision (or target measurement uncertainty) requirements to drug substance and drug product assays. They are based on the simple and well-known concept of the normal distribution probability around true content values represented either by manufacturing range limits, or by the manufacturing target (usually 100% label claim). A maximum acceptable precision is derived which allows a defined probability of analytical results within the established acceptance limits of th...

The impact of CYP2D6 mediated drug-drug interaction: a systematic review on a combination of metoprolol and paroxetine/fluoxetine.

Metoprolol (a CYP2D6 substrate) is often co-prescribed with paroxetine/fluoxetine (a CYP2D6 inhibitor) because the clinical relevance of this drug-drug interaction (DDI) is still unclear. This review aimed to systematically evaluate the available evidence and quantify the clinical impact of the DDI.


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